Apparatus and method for providing a reference indication to a patient tissue

ABSTRACT

An apparatus for providing a reference indication to a patient tissue includes a primary locating block having a patient-specific primary mating surface contoured for mating contact with a portion of the patient tissue in a predetermined primary mating orientation custom-configured responsive to preoperative imaging of the patient tissue. At least one mounting feature is provided to the primary locating block. At least one secondary item is configured for selective engagement with the primary locating block. The secondary item is at least one of a noncustomized secondary item and a patient-specific secondary item. The secondary item provides a reference indication to at least a portion of the patient tissue. The mounting feature of the primary locating block is configured for engagement with at least one secondary item in a predetermined secondary mounting relationship. The secondary mounting relationship is custom-configured for the patient tissue responsive to preoperative imaging of the patient tissue.

RELATED APPLICATION

This is a continuation non-provisional application Ser. No. 14/628,781filed on Feb. 23, 2015 which is a continuation non-provisionalapplication Ser. No. 13/472,662 filed on May 16, 2012 which claimspriority from U.S. Provisional Application No. 61/487,908, filed 19 May2011, the subject matter of which is incorporated herein by reference inits entirety.

TECHNICAL FIELD

The present invention relates to an apparatus and method for providing areference indication to a patient tissue and, more particularly, to amethod and apparatus for guiding resection and modification of a patienttissue to receive a prosthetic implant component in a desired implantposition.

BACKGROUND OF THE INVENTION

Minimally invasive surgery (“MIS”) is quickly becoming standard for theimplantation of prosthetic components into a patient. For example, theuse of an MIS shoulder replacement technique involves a skin incision ofapproximately 7-9 cm and is performed without the previously requiredlaying-open of the patient's entire shoulder area. MIS techniques forjoint replacement may reduce trauma to the patient, with less pain, lessblood loss, shorter convalescence, faster stabilization, and fewerpost-operative restrictions on exercising of the joint. The use of MISmay also give the prosthetic joint a better fixation and function thantraditional surgery, which in turn can contribute to an increasedlifetime for the prosthetic joint. MIS also can be done withconsiderably shorter hospitalization time than traditional techniques,and may even be available for outpatient procedures, providing aneconomic benefit linked to positive patient outcome in many cases.

In a prosthetic shoulder joint replacement, whether accomplished via MISor any other suitable surgical technique, the humeral head is removedand replaced with a prosthetic head which is fixed to the bone using astem within the humeral metaphysis and/or diaphysis shaft. The humeralhead articulates with the native glenoid (hemiarthroplasty) or with aprosthetic glenoid component. The humeral osteotomy is made at or nearthe anatomic neck of the humerus. This osteotomy defines a humeral headneck shaft angle and version of the final implant. In patients withdeformity associated with arthritis, the anatomic neck is difficult todefine, making it difficult for the surgeon to determine to preciselocation of this osteotomy. Standard generic stock cutting guidescurrently used for this procedure still require the surgeon to identifythese anatomic landmarks to place the cutting guides.

One factor which may lead to success for a total shoulder replacementtechnique is the provision of a clear overall view of the wound duringthe operation in order to achieve precise surgery and the desiredpositioning for the prosthetic components. In the precise surgeryassociated with the implantation of a shoulder replacement prostheticcomponent, it is important for the head of the humerus to be removedwith great precision. For this purpose an osteotomy template isgenerally used, whereby the level and orientation of the planned cuttingplane is transferred to the patient's humerus to guide the surgeon. Withthe preoperative planning procedures that are currently underdevelopment, a computer model of the patient's humerus will often beproduced, based on CT, radiographic, or other preoperatively obtainedimages. Based on this model, a desired cutting plane for the patient'shumerus can be determined.

Osteotomy templates exist for use in conventional surgery, but there iscurrently a need for improved osteotomy templates. A resection guide foruse in many hip, shoulder, or other types of prosthetic replacements,whether using MIS or another surgical style, would be useful thancurrently used guides by being considerably smaller, intended forinsertion through different openings, employing different anatomicallandmarks, allowing for a more accurate osteotomy, and easier toposition in the planned position than the currently used resectionguides.

Since traditional osteotomy templates are not adapted to the individualpatient, they require the surgeon to remove pathologic bone to identifylandmarks in order to place the template and make a cut or to use theanatomic landmarks to make an osteotomy without any template or cuttingguide. The difficulty lies in the surgeon's ability to identify anatomiclandmarks in the pathologic condition. This means that for patients withanatomical deviations, there is a reduction in precision withtraditional multi-use osteotomy templates, thereby giving a final resultthat is not optimal. For patients with greater anatomical deviations,moreover, the majority of multi-use templates will be difficult to useon account of limitations in the possibilities for adjustment. Even forpatients without great deviations, when using multi-use templates itwill be necessary to carry out adjustments of the osteotomy templateduring the operation, resulting in an increased risk of error, increasedoperating time and thereby an increased risk of complications.

SUMMARY OF THE INVENTION

In an embodiment of the present disclosure, there is provided anapparatus for providing a reference indication to a patient humerus, theapparatus comprising: a primary locating block including apatient-specific primary mating surface contoured and configured formating contact with at least a portion of a diaphysis of the humerus,the primary mating surface being custom-configured to mate with thehumerus in a predetermined primary mating orientation responsive topreoperative imaging of the patient humerus, and at least one mountingfeature; and at least one secondary item configured for selectiveengagement with the primary locating block and including apatient-specific secondary mating surface being contoured and configuredfor mating contact with at least a portion of the epiphysis of thehumerus, the secondary item being custom-configured to mate with thehumerus in a predetermined secondary mating orientation responsive topreoperative imaging of the humerus, the secondary mating orientationbeing non-coincident with the primary mating orientation, and thesecondary item providing a first reference indication to the portion ofthe epiphysis of the humerus; wherein the mounting feature of theprimary locating block is configured for engagement with the at leastone secondary item in a predetermined secondary mounting relationship,the secondary mounting relationship being custom-configured for thepatient humerus responsive to preoperative imaging of the patienthumerus such that the primary locating block and the at least onesecondary item are in the predetermined secondary mounting relationshipwhen respectively and concurrently in said mating contact with at leastthe diaphysis and the epiphysis of the patient humerus.

In an embodiment of the present disclosure, there is provided a methodof providing a reference indication to a patient humerus, the methodcomprising: obtaining a primary locating block including apatient-specific primary mating surface contoured and configured formating contact with at least a portion of a diaphysis of the humerus,and at least one mounting feature; mating the primary mating surfacewith the patient humerus in a primary mating orientation predeterminedat least partially responsive to preoperative imaging of the patienttissue; obtaining at least one secondary item including apatient-specific secondary mating surface being contoured and configuredfor mating contact with at least a portion of the epiphysis of thehumerus; engaging the mounting feature of the primary locating blockwith the at least one secondary item in a predetermined secondarymounting relationship, the secondary mounting relationship beingcustom-configured for the patient humerus responsive to preoperativeimaging of the patient humerus; and mating the secondary mating surfacewith the patient humerus in a secondary mating orientation predeterminedat least partially responsive to preoperative imaging of the patienthumerus, the secondary mating orientation being non-coincident with thefirst mating orientation; obtaining a first reference indication to atleast a portion of the patient humerus with the secondary item when theprimary mating surface and the secondary mating surface are respectivelyand concurrently in said mating with at least the diaphysis and theepiphysis of the patient humerus.

In an embodiment of the present invention, a system for facilitating atleast one of resection, repositioning, drilling, trimming, andconfiguration verification of a patient tissue of a long bone isprovided. A primary locating block includes a patient-specific primarymating surface contoured for mating contact with a nontarget portion ofthe long bone. The primary mating surface is custom-configured to matewith the nontarget portion of the patient tissue in a predeterminedprimary mating orientation responsive to preoperative imaging of thelong bone. At least one mounting feature is provided to the primarylocating block. At least one secondary item is configured for selectiveengagement with the primary locating block. The secondary item is atleast one of a noncustomized stock secondary item and a patient-specificsecondary item. The secondary item provides a reference indication to atleast a portion of the long bone to facilitate at least one ofresection, repositioning, drilling, trimming, and configurationverification of a target portion of a long bone. The mounting feature ofthe primary locating block is configured for engagement with at leastone secondary item in a predetermined secondary mounting relationship.The secondary mounting relationship is custom-configured for the longbone responsive to preoperative imaging of the long bone.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, reference may be made tothe accompanying drawings, in which:

FIG. 1 is a perspective side view of a configuration of an embodiment ofthe present invention;

FIGS. 2A-2E are individual perspective views of various components ofthe embodiment of FIG. 1;

FIG. 3 is a side view of an example use environment for the embodimentof FIG. 1;

FIGS. 4-9 illustrate a sequence of operation of the embodiment of FIG. 1in the use environment of FIG. 3;

FIG. 10 schematically depicts a surgical step in the sequence ofoperation of FIGS. 4-9; and

FIG. 11 is a perspective side view of a configuration of an embodimentof the present invention.

DESCRIPTION OF EMBODIMENTS

In accordance with the present invention, FIG. 1 depicts an exampleconfiguration of an apparatus 100 for providing a reference indicationto a patient tissue (omitted from the view of FIG. 1) and which may beused for guiding resection and modification of a patient tissue toreceive a prosthetic implant component in a desired implant position, orfor any other desired purpose. The patient tissue is shown and describedherein at least as a humeral long bone and the implant component isshown and described herein at least as a humeral prosthetic shouldercomponent of a known type having a stem inserted into a bored-outhumeral intramedullary canal. However, the patient tissue andcorresponding implant component could be any desired types such as, butnot limited to, hip joints, shoulder joints, knee joints, ankle joints,phalangeal joints, metatarsal joints, spinal structures, long bones(e.g., fracture sites), or any other suitable patient tissue useenvironment for the present invention. For example, the implantcomponent could be an internal fixation device (e.g., a bone plate), astructure of a replacement/prosthetic joint, or any other suitableartificial device to replace or augment a missing or impaired part ofthe body. The implant component will be described herein as a prostheticimplant component.

The apparatus 100 includes a primary locating block 102 and at least onesecondary item 104 configured for selective engagement with the primarylocating block. The primary locating block 102 includes apatient-specific primary mating surface 106 which is contoured formating contact with at least a portion of the patient tissue. The term“mating” is used herein to indicate a relationship in which the contoursof two structures are at least partially matched or coordinated in atleast two dimensions. For example, both the primary mating surface 106and the patient tissue surface could have profiles that are concavelycurved, convexly curved, planar/linear, or any combination of those orother profile shapes. The primary mating surface 106 may becustom-configured to mate with the patient tissue in a predeterminedprimary mating orientation responsive to preoperative imaging of thepatient tissue. The primary locating block also may include at least onemounting feature 108 (two shown).

FIGS. 2A-2E are individual perspective views of various components ofthe apparatus 100 shown in FIG. 1, and include detail on the secondarymounting relationships between each secondary item 104 and the primarylocating block 102. FIGS. 2A and 2B depict different aspects of theprimary locating block 102. The primary mating surface 106 of theprimary locating block 102 is shown in the view of FIG. 2A. While it ispossible for the primary mating surface 106 to be substantiallytwo-dimensional (e.g., an irregular line) for substantially linearcontact with the patient tissue, it is contemplated that, for manyapplications of the present invention, the primary mating surface 106will be three-dimensional for mating with a corresponding part or layerof the patient tissue, as shown in FIGS. 2A and 2B.

The secondary item 104′ shown in FIGS. 1 and 2C includes a positioningindicator 210 which can help to verify the position of at least aportion of the apparatus 100 with respect to the patient tissue. Inorder to do so, the positioning indicator 210 has a patient-specificsecondary mating surface 212 which may be custom-configured to mate witha portion of the patient tissue in a predetermined secondary matingorientation responsive to preoperative imaging of the patient tissue.The secondary mating orientation may be non-coincident with the primarymating orientation. That is, the portion of the patient tissue matedwith the secondary mating surface 212 may be different from the portionof the patient tissue mated with the primary mating surface 106, thoughthe two portions of the patient tissue may be adjacent or evencontiguous, depending upon the configuration of the apparatus 100. Theproperty of “non-coincidence” is independent of the timing of the matingof the surface(s) with the patient tissue, as the primary and secondarymating surfaces 106 and 212 could be non-coincidently mated with thepatient tissue at the same time/duration or at differenttimes/durations.

Other options for secondary items 104 include a cutting indicator 214,such as that shown with the secondary item 104″ of FIG. 2D, and a drillguide 216, such as that shown with the secondary item 104′″ of FIG. 2E.A cutting indicator 214, when present, is configured for a guidingrelationship with a cutting implement performing at least one of aresection and a trimming of the patient tissue. A “guiding relationship”is used herein to indicate that the “guiding” component steadies and/ordirects the motion of the “guided” component. For reasons which willlater become apparent, a rim 218 of the secondary item 104′″ of FIG. 2Emay also serve as a cutting indicator 214. A drill guide 216, whenpresent, guides a penetrating implement into the patient tissue.

Each mounting feature 108 of the primary locating block 102 may beconfigured for engagement with at least one secondary item 104 in thepredetermined secondary mounting relationship. For example, thesecondary item 104 could include a secondary mounting feature 220 forengagement with the mounting feature 108 of the primary locating block102 in the predetermined secondary mounting relationship. The secondarymounting relationship may be custom-configured for the patient tissueresponsive to preoperative imaging of the patient tissue, and may bemade patient-specific by a configuration of the mounting feature 108and/or the secondary item 104. It is contemplated that, for mostapplications of the present invention, there will only be one reasonablesecondary mounting relationship for each secondary item 104 with theprimary locating block 102, to provide the user with a high degree ofconfidence that the preoperatively planned reference indications arebeing transferred reliably to the actual patient tissue. Keys and/orslots, located on one or both of the primary locating block 102 and thesecondary item 104, may be used to help guide and/or secure thesecondary item in a predetermined relationship with the primary locatingblock.

Optionally, at least one anchoring feature could be provided to one orboth of the primary locating block 102 and the secondary item(s) 104 forproviding at least one of securement, stability, and position indicationfor that portion of the apparatus 100 relative to the patient tissue.For example, and as shown in FIGS. 2A and 2B, the anchoring featureincludes a plurality of anchoring structures 222 which are eachconfigured to guide an anchoring pin (not shown) into the patient tissueat a predetermined location and trajectory.

(The location and/or trajectory could be preoperatively chosen, forexample, to anchor into solid patient tissue or to avoid disturbingpathologic patient tissue.) In the FIGS. 2A and 2B arrangement, theanchoring pin(s) are operative to provide at least one of securement,stability, and position indication for the primary locating block 102relative to the patient tissue in the primary mating orientation, aswill be discussed below. Similarly, as shown in FIG. 2E, the secondaryitem 104′″ can include one or more anchoring structures 222 which may beused in cooperation with an anchoring pin (not shown) to provide atleast one of securement, stability, and position indication for thesecondary item relative to the patient tissue at a predeterminedlocation, whether or not the anchoring structure(s) of the secondaryitem provide trajectory guidance.

Using the positioning indicator 210, cutting indicator 214, drill guide216, and/or any other suitable structure, the secondary item104—whatever its specific configuration—may facilitate at least one ofresection, repositioning, drilling, trimming, and configuration (e.g.,positioning) verification of the patient tissue. These and similarproperties are referenced collectively herein as providing “referenceindication” to the patient tissue. Reference indication may be useful,for example, in physically transferring preoperatively planned virtualdimensions, angles, resection locations, and other physical propertiesto the actual patient tissue. To aid this effort, a predeterminedsecondary mounting relationship may be provided to the apparatus 100.

As shown in FIGS. 2A and 2B, the primary locating block 102 may includeone or more mounting features 108, with the depicted example embodimentincluding a keyed female-type mounting feature 108′ and a keyedmale-type mounting feature 108″, both of which are configured toremovably accept a correspondingly shaped secondary mounting feature 220in a male-to-female (or female-to-male) mounting relationship. By way ofexample, the secondary item 104′ of FIG. 2C is depicted as including amale-type secondary mounting feature 220 configured for mating with thekeyed female-type mounting feature 108′, and the secondary items 104″and 104′″ of FIGS. 2D and 2E both are depicted as including a ring-typefemale-type secondary mounting feature (including a cylindrical featureextending circumferentially around all or part of the mounting feature108″) for mating with the keyed male-type mounting feature 108″, thoughany suitably-structured mounting features 108 may be provided by one ofordinary skill in the art. The “keyed” features, when present, mayinclude cavities 224 and/or protrusions 226 on either or both of theprimary locating block 102 and the secondary item 104, or any otherstructures which may help to positively locate, and optionally helpmaintain, the structures of the apparatus 100 in the predeterminedsecondary mounting relationship. Optionally, a securement aperture 228could be provided in either or both of the primary locating block 102and the secondary item 104 to accept a pin, bolt, screw, nail, wire, orother fastener to help maintain the structures of the apparatus 100 inthe predetermined secondary mounting relationship.

Because at least the primary mating surface 106 portion of the primarylocating block 102 is contemplated to be custom-manufactured for eachpatient, it also may be possible to custom-configure the mountingfeature(s) 108 of the primary locating block, as well, to accept asecondary item 104 in a particular patient-specific orientation. Forexample, the keyed female-type mounting feature 108′ and/or the keyedmale-type mounting feature 108″ could have appropriate configurations,optionally including cavities 224 and/or protrusions 226 havingpredetermined relationships with the primary mating surface 106 so thatany secondary item 104 mated to the mounting feature will extendtherefrom at a predetermined angle. Stated differently, though the keyedmale-type mounting feature 108″ has a cavity 224 at a particular angularrelationship with respect thereto, that cavity 224 could be rotatedaround the circumference of the mounting feature 108″ so that the cavity224 is located in another angular relationship with respect to themounting feature (e.g., further clockwise or counterclockwise, in theorientation of FIG. 2B), which will result in a mated secondary item 104achieving a desired and potentially patient-specific orientation withthe primary mating surface 106 and, by extension, with the patienttissue.

One of ordinary skill in the art will understand that the secondarymounting relationship, in which a secondary item 104 is held (usuallyremovably held) by the primary locating block 102 in a predeterminedrelative position, may be made patient-specific by the arrangement andconfiguration of the mounting feature 108 which interacts with thesecondary item. The secondary mounting relationship also or instead canbe made patient-specific by the arrangement and configuration of thesecondary mounting feature 220 (of the secondary item 104) whichinteracts with the primary locating block 102 (e.g., the arrangement andconfiguration of the cavities 224, protrusions 226, or any other portionof the secondary mounting feature 220 or any mounting feature 108 of theprimary locating block). In this manner, one of ordinary skill in theart will be able to design a patient-specific component of the apparatus100 (e.g., the primary locating block 102) which interacts with one ormore stock or non-patient-specific components of the apparatus (e.g.,the secondary item(s) 104) to provide some degree of patient-specificityin the apparatus as a whole. This patient-specificity of an apparatus100 for providing a reference indication may be desirable forfacilitating a surgical operation and might otherwise be unavailable,prohibitively expensive, and/or undesirably time-consuming to achieve.

An example patient tissue use environment for an apparatus 100 accordingto an embodiment of the present invention is shown in FIG. 3. Thepatient tissue depicted in FIG. 3 is a long bone, more specifically ahumerus 324, though the apparatus 100 may be used with any suitablepatient tissue. The central portion of the humerus 324 is a diaphysis(shown approximately at 326), with an epiphysis (shown approximately at328) at either end of the humerus. The below description presumes thatthe humeral head 330 (the epiphysis 328 on the right side of the page,in the orientation of FIG. 3) is being resected and the intramedullarycanal (i.e., the interior of the diaphysis 326) is being broached,reamed, and/or drilled out to accept a stem of a humeral prostheticshoulder joint component, with at least a portion of the surgicalprocedure being performed with the assistance of the apparatus 100. Theapparatus 100, shown in various optional configurations in FIGS. 1 and4-9, may be at least partially custom-manufactured for a particularpatient responsive to preoperative imaging of the patient tissue. Forexample, the apparatus 100, or portions thereof, may be whollycustom-made (e.g., using rapid prototyping techniques) or may bemodified from a stock guide or guide blank (not shown). It iscontemplated that at least a part of the apparatus 100 is apatient-specific, single-use, bespoke feature suited only for use at theindicated surgical site, though one of ordinary skill in the art couldcreate an apparatus—or components thereof—which uses a patient-specific“disposable” structure connected to a stock, generic “reusable” carrier(e.g., a reusable secondary item 104′ could carry adisposable/replaceable positioning indicator 210). However, for cost andcomplexity reasons, users of the apparatus 100 in particularapplications of the present invention may prefer to have apatient-specific and disposable primary locating block 102 and anassortment of both reusable and patient-specific/disposable secondaryitems 104, and this is the situation that will be presumed in the belowdescription.

Regardless of the whole/partial custom manufacture status, the apparatus100 may be configured responsive to at least one of preoperative imagingof the patient tissue and preoperative selection of the stock prostheticimplant. For example, a system similar to that of co-pending U.S.Provisional Patent Application No. 61/408,392, filed Oct. 29, 2010 andtitled “System of Preoperative Planning and Provision ofPatient-Specific Surgical Aids” (the entire contents of which areincorporated herein by reference), or any suitable preoperative planningsystem, could be used. In this manner, a user can create a patienttissue model for observation, manipulation, rehearsal, or any otherpreoperative tasks.

The term “model” is used herein to indicate a replica or copy of aphysical item, at any relative scale and represented in any medium,physical or virtual. The patient tissue model may be a total or partialmodel of a subject patient tissue, and may be created in any suitablemanner. For example, and as presumed in the below description, thepatient tissue model may be based upon computer tomography (“CT”) dataimported into a computer aided drafting (“CAD”) system. Additionally oralternatively, the patient tissue model may be based upon digital oranalog radiography, magnetic resonance imaging, or any other suitableimaging means. The patient tissue model will generally be displayed forthe user to review and manipulate preoperatively, such as through theuse of a computer or other graphical workstation interface.

During preoperative planning, the user can view the patient tissue modeland, based upon knowledge of other patient characteristics (such as, butnot limited to, height, weight, age, and activity level), choose adesired stock prosthetic implant. Because three-dimensional image modelsare available of many stock prosthetic implants, the user may be able to“install” the stock prosthetic implant virtually in the patient tissuemodel via a preoperative computer simulation. During such a simulation,the user can adjust the position of the stock prosthetic implant withrespect to the patient tissue, even to the extent of simulating thedynamic interaction between the two, to refine the selection, placement,and orientation of the stock prosthetic implant for a desired patientoutcome.

Once a chosen stock prosthetic implant has been virtually placed in adesired position and orientation with respect to the patient tissue, itwill be understood that some mechanical modification—including, but notlimited to, resection, repositioning, drilling, trimming—might need tobe made to the native patient tissue to accomplish the desiredprosthetic implant placement. The modification information for theparticular patient tissue achieved via preoperative imaging and/orcomputer simulation/modeling may be transferred to a physical aid forthe user through the custom manufacture of an apparatus 100. When thepreoperative planning has been finalized, a virtual apparatus 100 may begenerated, having particular characteristics chosen with respect to thevirtual implant and the virtual patient tissue. The user may then havethe opportunity to adjust the virtual implant, if desired, before aphysical implant is produced.

The patient's name, identification number, surgeon's name, and/or anyother desired identifier may be molded into, printed on, attached to, orotherwise associated with the apparatus 100, or portions thereof, in alegible manner. The apparatus 100 may be made of any suitable materialor combination of materials, and may be created using any suitablemethod such as, but not limited to, selective laser sintering (“SLS”),fused deposition modeling (“FDM”), stereolithography (“SLA”), laminatedobject manufacturing (“LOM”), electron beam melting (“EBM”),3-dimensional printing (“3DP”), contour milling from a suitablematerial, computer numeric control (“CNC”), other rapid prototypingmethods, or any other desired manufacturing process.

Regardless of how the components thereof were provided, FIG. 4 depicts apatient-specific secondary item 104′ which has been brought intoselective engagement with the primary locating block 102 in apredetermined secondary mounting relationship to form an apparatus 100,which has been positioned in contact with the humerus 324. The primarymating surface 106 of the primary locating block 102 has been placedinto a predetermined primary mating orientation with a nontarget portionof the humerus 324—i.e., a portion of the humerus which is relativelyconstant and unchanging during the use of the apparatus 100, and thesecondary mating surface 212 of the secondary item 104′ has been placedinto a predetermined secondary mating orientation with a target portionof the humerus. In the example of FIGS. 4-9, the nontarget portion ofthe humerus 324 includes at least a portion of the diaphysis of thehumerus, and a target portion of the humerus includes at least a portionof the epiphysis 328 of the humerus.

As shown in FIG. 4, the secondary item 104′ is of the type whichincludes a positioning indicator 210, and a secondary mating surface 212of the positioning indicator mates with a predetermined portion of thehumeral head 330 to help confirm the position of the apparatus 100 withrespect to the humerus 324, and optionally to help steady the primarylocating block 102 during the initial stages of use of the apparatus inthe surgical procedure. (Both of these functions of the secondary item104′ may be considered the provision of a reference indication.) Here,the primary mating surface 106 of the primary locating block 102 hasbeen mated with at least a portion of the bicipital groove (not shown).Once the user is reasonably confident that the primary locating block102 is in the desired primary mating orientation with respect to thehumerus 324, one or more anchoring pins 432 may interact with respectiveanchoring structures 222 to substantially secure the primary locatingblock 102 to the humerus in the aforementioned manner.

Turning to FIG. 5, the patient-specific secondary item 104′ has beenleft in the secondary mounting relationship with the keyed female-typemounting feature 108′ (optionally to steady the apparatus 100 duringthis phase of surgery), and a stock (non-patient-specific) secondaryitem 104″ has been placed into a secondary mounting relationship withthe keyed male-type mounting feature 108″ of the primary locating block102. A cutting indicator 214 (here, a slot in the secondary item 104″)has been placed at a desired cutting plane location for resection of thehumeral head 330. Although the secondary item 104″ is a stock component,one of ordinary skill in the art can readily understand, with referenceto FIG. 5, how arrangement and orientation of the keyed male-typemounting feature 108″ of a patient-specific primary locating block102—e.g., setting a desired rotation position of the cavity 224 withrespect to the rest of the mounting feature 108″—will dictate a desiredpatient-specific secondary mounting relationship sufficient to placeeven a stock secondary item 104″ in a desired relative position to thehumeral head 330. For example, the secondary mounting relationship couldbe adjusted during preoperative planning to configure a patient-specificprimary locating block 102 and thereby place the cutting indicator 214at a desired angle with respect to the humeral head 330.

As shown, the secondary item 104″ includes a cutting indicator 214 whichis a slot configured to accept and guide a surgical saw to resect thehumeral head 330 as desired. The secondary item 104″ also or insteadcould guide a surgical saw or other cutting instrument along a topguiding surface 534 thereof to perform the desired resection. Becausethe surgical saw or other cutting instrument is sharp and may moveunpredictably due to irregularities in the patient tissue, or due toimprecise use of the tool, it may be desirable for the secondary item104″ containing the cutting indicator 214 to be at least partially madeof metal or other material(s) that are durable and generally resistantto being fragmented. The material choice should be selected to avoidshedding of debris from the secondary item 104″ into the patient'stissue due to contact between the tool and the secondary item. A metal(or other durable-material) patient-specific construct may be difficultand/or expensive to fabricate, however. The present invention providesfor the use of a stock, non-patient-specific secondary item 104″ to bereused for multiple patients because the configuration of the primarylocating block 102 and the specifics of the secondary mountingrelationship allow patient-customization of the guiding function of thecutting indicator 214 without requiring patient-customization of thesecondary item 104″ containing that cutting indicator.

In FIG. 6, the humeral head 324 has been removed along a prescribedcutting plane to leave an osteotomy surface 636. The secondary items104′ and 104″ have been removed from the mounting features 108′ and108″, respectively, leaving the primary locating block 102 anchored tothe nontarget tissue of the humerus 324 by the anchoring pins 432interacting with the anchoring structures 222.

Continuing to FIG. 7, a patient-specific secondary item 104′″ has beenplaced into a secondary mounting relationship with the mounting feature108″ of the primary locating block 102, while mounting feature 108′ hasbeen left empty. Secondary item 104′″ includes an osteotomy plate 738which extends at a predetermined angle from the locating block 102 whenthe secondary item 104′″ is in the secondary mounting relationship. Itis contemplated that this angle will bring the osteotomy plate 738 intosubstantially full contact with the osteotomy surface 636 of the humerus324 and therefore serve as a positioning indicator by providing areference indication that either verifies that the humeral head 330 wasresected according to the preoperative plan or guides additionalmachining operations to correct a resection that did not occur asplanned.

FIGS. 8 and 9 depict various additional views of the arrangement of FIG.7, though the apparatus 100 remains substantially unchanged from theview of FIG. 7 to the view of FIG. 8. In FIG. 8, a top view of theosteotomy surface 636 and overlying osteotomy plate 738 is shown.Optionally, and as depicted here, the osteotomy plate 738 may bear arelationship to the prosthetic shoulder joint component being installedsuch that the osteotomy plate represents a “footprint” of the prostheticshoulder joint component. Additionally or alternately, the osteotomyplate 636 can have a perimeter/profile shape chosen by the user (notnecessarily based upon a prosthetic component) to act as a template orguide to help impart/transfer any desired shape or borders to thehumerus 324 or another remaining patient tissue structure. Whether ornot this implant “footprint” relationship is present, portions of theosteotomy surface 636 visible from above and located lateral to the rim218 of the secondary item 104′″ may be undesirable osteophytes 838 andmay be removed by the user to smooth the eventual interface between thehumerus 324 and the prosthetic shoulder joint component. In this way,the rim 218 acts as a template or cutting indicator 216 to guide theuser in resecting or otherwise removing undesirable patient tissueduring the surgical procedure.

In FIG. 9, the osteophytes 838 have been removed, and the orientation ofthis Figure instead emphasizes the drill guide 216 of the secondary item104′″. The secondary item 104′″ includes a drill guide 216 for providinga reference indication to guide drilling, broaching, rasping, or othermachining of the diaphysis 326 to accommodate a penetrating portion ofthe prosthetic shoulder joint component. One or more removable drillguide spacers 940 could be associated, as a group or singly, with thedrill guide 216. (As shown here, the drill guide spacer(s) 940 arenested within the drill guide 216 and may serve as “bushings” to shieldcontact between the drill guide and the drill or other tool beingguided.) Through sequential use of the drill guide spacer(s) 940, asuccession of drilling, broaching, rasping, or other machiningoperations can be guided to gradually enlarge an aperture in the patienttissue through use of successively larger tools. The drill guide 216 maybe patient-specific to guide a drill 1042 or other penetrating implement(shown schematically in FIG. 10) to carry out a preoperatively planneddrilling or other penetrating procedure at a predetermined locationhaving a desired relationship to the body of the humerus 324.Optionally, the drill guide 216 may also include a drill stop (e.g., anupper rim of the drill guide structure) which provides a referenceindication or even restricts excessive penetration of the penetratingimplement into the intramedullary canal of the diaphysis 326.

When the desired reference indications have all been performed, theapparatus 100 may be removed from the patient tissue and the surgicalprocedure can then proceed apace. The patient-specific portions of theapparatus 100 are discarded and the stock or non-patient-specificportions of the apparatus 100 are sterilized and returned to inventoryfor later use with other patients.

The secondary mounting relationship shown in the Figures includes amale-to-female frictional fitting interaction between the mountingfeature(s) 108 of the primary locating block 102 and the secondarymounting feature(s) 220 of the secondary item(s) 104. It is contemplatedthat the frictional fit between these two components be firm enough toretain the secondary item(s) 104 in engagement with the primary locatingblock 102 until the user exerts a reasonable force to remove thesecondary item(s) from the primary locating block. Generally, the userwill wish to perform this removal without dislodging the primarymounting surface 106 from the patient tissue. However, one of ordinaryskill in the art can readily provide mounting feature(s) 108 of theprimary locating block 102 and secondary mounting feature(s) 220 of thesecondary item(s) 104 which interact and engage together in any desiredmanner, and using any desired intermediary fastening means/techniques,such as, but not limited to, adhesives, frictional engagement of anytype (e.g., male/female roles reversed from those shown), additionalfasteners (e.g., cotter pins), threadable engagement, captured-ballmechanisms, external-collar mechanisms, magnets, securement aperture(s)228, any other suitable mounting feature types, or any combinationthereof.

Additionally, one of ordinary skill in the art could also providesymmetrical or otherwise non-directional/non-patient-specific mountingfeature(s) 108 of the primary locating block 102 and/or secondarymounting feature(s) 220 of the secondary item(s) 104 which can fittogether in many different secondary mounting relationships. In order tomake such an arrangement patient-specific, the mounting feature(s) 108of the primary locating block 102 and/or secondary mounting feature(s)220 of the secondary item(s) 104 could include visual indicators (e.g.,a radial/degree scale on one or both of the mating mounting features 108and 220) to assist the user with achieving a desired predeterminedrelative position between the primary locating block and the secondaryitem when in the secondary mounting relationship.

FIG. 11 depicts an apparatus 100 according to a second embodiment of thepresent invention. The apparatus 100 of FIG. 11 is similar to theapparatus 100 of FIGS. 1-9 and therefore, structures of FIG. 11 that arethe same as or similar to those described with reference to FIGS. 1-9have the same reference numbers with the addition of a lower-case “a”.Description of common elements and operation similar to those in thepreviously described embodiment will not be repeated with respect to thesecond embodiment.

As shown in FIG. 11, the primary locating block 102 a may include one ormore mounting features 108 a, with the depicted example embodimentincluding a quarter-round mounting feature 108′a and an ell-shapedmounting feature 108″a, both of which are configured to removably accepta correspondingly shaped secondary mounting feature 220 a in amale-to-female mounting relationship. The secondary items 104 a of FIG.11 includes a quarter-round secondary mounting feature 220 a for matingwith the quarter-round mounting feature 108′a, and another secondaryitem (not shown) for use with the second embodiment of FIG. 11 mightinclude an ell-shaped secondary mounting feature for mating with theell-shaped mounting feature 108″a. Because at least the primary matingsurface 106 a portion of the primary locating block 102 a iscontemplated to be custom-manufactured for each patient, it also may bepossible to custom-configure the mounting feature(s) 108 a of theprimary locating block, as well, to accept a secondary item 104 a in aparticular patient-specific orientation. For example, the quarter-roundmounting feature 108′a and/or the ell-shaped mounting feature 108″acould be placed into a particular angular relationship with the primarymating surface 106 a so that any secondary item 104 a mated to themounting feature will extend therefrom at a predetermined angle. Stateddifferently, though the ell-shaped mounting feature 108″a has a vertexpointing toward the right in the orientation of FIG. 11, that ell shapecould be rotated so that the vertex points in any other desireddirection (e.g., up, down, to the left, etc.) which will result in amated secondary item 104 a achieving a desired orientation with theprimary mating surface 106 a and, by extension, with the patient tissue.

One of ordinary skill in the art can readily understand, with referenceto FIG. 11, how arrangement and orientation of the quarter-roundmounting feature 108′a and/or the ell-shaped mounting feature108″a—e.g., setting a desired rotation position of the quarter-round orell-shape with respect to the rest of the primary locating block 102a—will dictate a desired patient-specific secondary mountingrelationship sufficient to place the secondary item 104 a in a desiredrelative position to the humeral head 330 a. For example, the secondarymounting relationship could be adjusted during preoperative planning toplace a cutting indicator (not shown) at a desired angle with respect tothe humeral head.

While aspects of the present invention have been particularly shown anddescribed with reference to the preferred embodiment above, it will beunderstood by those of ordinary skill in the art that various additionalembodiments may be contemplated without departing from the spirit andscope of the present invention. For example, any of the describedstructures and components could be integrally formed as a single pieceor made up of separate sub-components, with either of these formationsinvolving any suitable stock or bespoke components and/or any suitablematerial or combinations of materials. It is contemplated that at leastone of the primary locating block 102 and secondary item(s) 104 may bereusable (optionally sterilizable), and at least one of the primarylocating block and secondary item(s) may be disposable. Though certaincomponents described herein are shown as having specific geometricshapes, all structures of the present invention may have any suitableshapes, sizes, configurations, relative relationships, cross-sectionalareas, or any other physical characteristics as desirable for aparticular application of the present invention. Any structures orfeatures described with reference to one embodiment or configuration ofthe present invention could be provided, singly or in combination withother structures or features, to any other embodiment or configuration,as it would be impractical to describe each of the embodiments andconfigurations discussed herein as having all of the options discussedwith respect to all of the other embodiments and configurations. Avariety of schemes are described herein for placing the apparatus 100into the predetermined position with respect to the patient tissue, andthese schemes can be used singly or in any suitable combination for aparticular application of the present invention. The matingrelationships formed between the described structures need not keep theentirety of each of the “mating” surfaces in direct contact with eachother but could include spacers or holdaways for partial direct contact,a liner or other intermediate member for indirect contact, or could evenbe approximated with intervening space remaining therebetween and nocontact. The apparatus 100, or portions thereof, could be anchored tothe patient tissue in any suitable manner, such as, but not limited to,adhesives, integral pegs, other fasteners, frictional engagement,magnets, securement aperture(s) 228, any other suitable mounting featuretypes, or any combination thereof. A device or method incorporating anyof these features should be understood to fall under the scope of thepresent invention as determined based upon the claims below and anyequivalents thereof.

Other aspects, objects, and advantages of the present invention can beobtained from a study of the drawings, the disclosure, and the appendedclaims.

1. An apparatus for providing a reference indication to a patienthumerus, the apparatus comprising: a primary locating block including apatient-specific primary mating surface contoured and configured formating contact with at least a portion of a diaphysis of the humerus,the primary mating surface being custom-configured to mate with thehumerus in a predetermined primary mating orientation responsive topreoperative imaging of the patient humerus, and at least one mountingfeature; and at least one secondary item configured for selectiveengagement with the primary locating block and including apatient-specific secondary mating surface being contoured and configuredfor mating contact with at least a portion of the epiphysis of thehumerus, the secondary item being custom-configured to mate with thehumerus in a predetermined secondary mating orientation responsive topreoperative imaging of the humerus, the secondary mating orientationbeing non-coincident with the primary mating orientation, and thesecondary item providing a first reference indication to the portion ofthe epiphysis of the humerus; wherein the mounting feature of theprimary locating block is configured for engagement with the at leastone secondary item in a predetermined secondary mounting relationship,the secondary mounting relationship being custom-configured for thepatient humerus responsive to preoperative imaging of the patienthumerus such that the primary locating block and the at least onesecondary item are in the predetermined secondary mounting relationshipwhen respectively and concurrently in said mating contact with at leastthe diaphysis and the epiphysis of the patient humerus.
 2. The apparatusof claim 1, further comprising at least another secondary itemconfigured for selective engagement with the primary locating block, theother secondary item being a noncustomized stock secondary itemproviding a second reference indication to the epiphysis distinct fromthe first reference indication, the mounting feature of the primarylocating block being configured for engagement with the other secondaryitem in another predetermined secondary mounting relationship.
 3. Theapparatus of claim 2, wherein the mounting relationship between theother secondary item and the primary locating item is madepatient-specific by a configuration of the other secondary item.
 4. Theapparatus of claim 2, wherein at least one of the secondary itemsincludes a cutting indicator for a guiding relationship with a cuttingimplement performing at least one of a resection and a trimming of thepatient humerus.
 5. The apparatus of claim 2, wherein at least one ofthe secondary items includes a drill guide for guiding a penetratingimplement into the patient humerus.
 6. The apparatus of claim 1, whereinthe secondary item includes a positioning indicator for verifying theposition of at least a portion of the apparatus with respect to thepatient humerus.
 7. The apparatus of claim 1, wherein the primarylocating block includes at least one anchoring feature for providing atleast one of securement, stability, and position indication for theprimary locating block relative to the patient humerus in the primarymating orientation.
 8. The apparatus of claim 7, wherein the anchoringfeature includes an anchoring structure configured to guide an anchoringpin into the patient tissue at a predetermined location and trajectory,the anchoring pin being operative to provide at least one of securement,stability, and position indication for the primary locating blockrelative to the patient humerus in the primary mating orientation. 9.The apparatus of claim 2, wherein at least one of the secondary itemsincludes a secondary mounting feature for engagement with the mountingfeature of the primary locating block in the predetermined secondarymounting relationship.
 10. The apparatus of claim 2, wherein thesecondary items facilitate at least one of resection, repositioning,drilling, trimming, and configuration verification of the patienttissue.
 11. A method of providing a reference indication to a patienthumerus, the method comprising: obtaining a primary locating blockincluding a patient-specific primary mating surface contoured andconfigured for mating contact with at least a portion of a diaphysis ofthe humerus, and at least one mounting feature; mating the primarymating surface with the patient humerus in a primary mating orientationpredetermined at least partially responsive to preoperative imaging ofthe patient tissue; obtaining at least one secondary item including apatient-specific secondary mating surface being contoured and configuredfor mating contact with at least a portion of the epiphysis of thehumerus; engaging the mounting feature of the primary locating blockwith the at least one secondary item in a predetermined secondarymounting relationship, the secondary mounting relationship beingcustom-configured for the patient humerus responsive to preoperativeimaging of the patient humerus; and mating the secondary mating surfacewith the patient humerus in a secondary mating orientation predeterminedat least partially responsive to preoperative imaging of the patienthumerus, the secondary mating orientation being non-coincident with thefirst mating orientation; obtaining a first reference indication to atleast a portion of the patient humerus with the secondary item when theprimary mating surface and the secondary mating surface are respectivelyand concurrently in said mating with at least the diaphysis and theepiphysis of the patient humerus.
 12. The method of claim 11, furthercomprising: obtaining at least another secondary item configured forselective engagement with the primary locating block, the othersecondary item being a noncustomized stock secondary item providing asecond reference indication to the epiphysis distinct from the firstreference indication, engaging the mounting feature of the primarylocating block with the other secondary item in another predeterminedsecondary mounting relationship, and obtaining the second referenceindication to the portion of the epiphysis of the patient humerus withthe other secondary item copied to the primary locating block and withthe primary mating surface in said mating with at least the diaphysis ofthe patient humerus.
 13. The method of claim 12, including engaging themounting feature of the primary locating block with the other secondaryitem is patient-specific by a configuration of the other secondary item.14. The method of claim 12, wherein at least one of the secondary itemsincludes comprises obtaining a cutting indicator, and the methodincludes the step of placing the cutting indicator into a guidingrelationship with a cutting implement performing at least one of aresection and a trimming of the patient humerus.
 15. The method of claim12, wherein at least one of the secondary items includes a drill guide,and the method includes the step of guiding a penetrating implement intothe patient tissue with the drill guide.
 16. The method of claim 11,wherein the secondary item includes a positioning indicator, and themethod includes the step of verifying the position of at least a portionof the apparatus with respect to the patient humerus with thepositioning indicator.
 17. The method of claim 11, including the step ofobtaining at least one of securement, stability, and position indicationfor the primary locating block relative to the patient humerus in theprimary mating orientation using an anchoring feature.
 18. The method ofclaim 17, wherein the anchoring feature includes an anchoring aperture,and the method includes the steps of: using the anchoring structure toguide an anchoring pin into the patient tissue at a predeterminedlocation and trajectory; and obtaining at least one of securement,stability, and position indication for the primary locating blockrelative to the patient humerus in the primary mating orientation withthe anchoring pin.
 19. The method of claim 12, wherein at least one ofthe secondary items includes a secondary mounting feature, and themethod includes the step of engaging the secondary mounting feature withthe mounting feature of the primary locating block in the predeterminedsecondary mounting relationship.
 20. The method of claim 12, wherein atleast one of the secondary items facilitates at least one of resection,repositioning, drilling, trimming, and configuration verification of thepatient tissue.